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DEFLECT III: Investigational brain shield appears to improve safety, cognition outcomes after TAVR
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SAN DIEGO — An investigational device designed to deflect debris away from the brain during transcatheter aortic valve replacement may improve safety outcomes and cognitive scores, according to findings from a preliminary study presented at the American College of Cardiology Scientific Sessions here.
During TAVR, particles are discharged from the clogged valve and float through the bloodstream, some of which move to the brain and can cause stroke or other damage, Alexandra J. Lansky, MD, director of the Yale Cardiovascular Research Program at Yale School of Medicine, said during a press conference. The device (TriGuard HDH, Keystone Heart) was designed to reduce the risk for brain damage after TAVR by covering the three cerebral vessels with a mesh shield, she said.
“The rate of stroke [in TAVR] is going down, but the rate of silent ischemic brain lesions is not,” she said.
In DEFLECT III, the first multicenter randomized clinical trial of an embolic protection device used during TAVR, researchers randomized 83 patients undergoing TAVR via the transfemoral or transapical approach to receive the device or not.
The primary endpoint was in-hospital major adverse CV and cerebrovascular events, defined as death, stroke, life-threatening or disabling bleeding, acute kidney injury and major vascular complications.
A composite of technical success metrics was achieved in 40 of the 46 patients in the device group, according to the researchers.
The primary endpoint was observed in 22.2% of the device group vs. 31.6% of controls (RR = 0.7; 95% CI, 0.34-1.45), Lansky said, noting that the finding shows the device is safe.
In the device group, there were 4.5 new lesions per patient vs. 4 in controls, but mean lesion volume was lower in the device group (73 mm3 vs. 88 mm3). In the intention-to-treat population, 21.9% of those in the device group had 0 total lesion volume, vs. 12.5% for controls; for the per-protocol population, it was 26.9% in the device group and 12.5% in the control group.
“With complete coverage of the cerebral vessels with the device, there is more reduction in lesion volumes on the order of 40% to 45%,” Lansky said. “What had never been shown before is a greater than 50% increased proportion of patients who have complete freedom from brain lesions, so we can achieve complete brain protection.”
Upon discharge, 97.4% of the device group had the same or better NIH Stroke Scale score vs. 87.9% of controls, according to the researchers. Montreal Cognitive Assessment scores were more likely to improve in the device group vs. controls, and were the same or better at discharge in 73.7% of the device group vs. 63.3% of controls.
“We are seeing signals that at discharge, patients who were protected with this device actually had better short-term memory and better delayed memory,” she said. “With protection, patients had better cognition on discharge compared to control patients.”
The results will be used to benchmark an Investigational Device Exemption trial, she said. – by Erik Swain
Reference:
Lansky AJ, et al. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.
Disclosure: The study was funded by Keystone Heart. Lansky reports receiving consultant fees/honoraria from CardioDX; holding equity in Keystone Heart; and serving on the speaker’s bureau for AstraZeneca, Daiichi Sankyo, Eli Lilly and Merck.
Perspective
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Howard C. Herrmann, MD
This was a relatively small feasibility trial that nonetheless demonstrates the potential benefit of avoiding emboli to the brain. Although major strokes were not reduced, the fact that the volume of particles to the brain were reduced in DEFLECT suggests that it may be possible to show benefit of embolic protection during TAVR. There was also a trend to improved cognitive function in the device arm. I believe that embolic protection will become an important adjunct procedure during TAVR.
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